BSI_May-2016_Raj Gunashekar

1An MM Activ Publication | www.biospectrumindia.com | May 2016 | BioSpectrum
Volume 14  Issue 5  May 2016 www.biospectrumindia.com
An Publication
`100
Totalpagesincludingcover68
EMERGING
NEW WAVE OF
THERANOSTICS
‘MAKE IN INDIA’ IMPACT ON BIOSCIENCES SECTOR ELECTRONIC WEARABLE INJECTOR A REALITY
BIOANALYSIS BIOSUPPLIERS
A COMBINATION OF DIAGNOSIS WITH
THERAPY GEARED TO REVOLUTIONIZE
THE WORLD OF HEALTHCARE.

ANNOUNCINGANNOUNCING
DECEMBER 02-05, 2016
RESHIMBAGH GROUND, NAGPUR
MAHARASHTRA, INDIA
Workshop National Expo Conference
Book Now and Avail Early Bird Offer!
Supported By Organized By
To be a Sponsor, Exhibitor, Delegate kindly contact: Agrovision Secretariat
New Delhi : Kusum +91 72760 01696 Ph.: +91-011-4354 2737
Nagpur: Vinay +91 97647 96709 Ph.: +91-0712-2544 929 | Pune: Dipak +91 99232 02884 Ph.: +91-20-2729 1769
Email : info@agrovisionindia.in | agrovisionnagpur@gmail.com
Connect With Us
#agrovisionindia
www.agrovisionindia.in

4 BioSpectrum | May 2016 | www.biospectrumindia.com | An MM Activ Publication
Volume 14  Issue 5  May 2016 www.biospectrumindia.com
An Publication
`100
EMERGING
NEW WAVE OF
THERANOSTICS
‘MAKE IN INDIA’ IMPACT ON BIOSCIENCES SECTOR ELECTRONIC WEARABLE INJECTOR A REALITY
BIOANALYSIS BIOSUPPLIERS
A COMBINATION OF DIAGNOSIS WITH
THERAPY GEARED TO REVOLUTIONIZE
THE WORLD OF HEALTHCARE.
COVER
DESIGN BY:
SHIHAB K A
BioContents
REGULARS
7BIOEDIT
8BIOMAIL
13BIONEWS
52BIOSUPPLIERS
53BIOPEOPLE
COVERSTORY 18
BIOSUPPLIERS
ELECTRONIC WEARABLE INJECTOR A REALITY55
BIOTALK
10
Dr Anne Lindblad
director, EMMES
WE HAVE NO
PLANS TO
LEAVE INDIA
40
Ms Elizabeth Bailey
Director, Consortium for Affordable
Medical Technologies (CAMTech)
INDIA WILL BECOME
A LEADER IN
MEDTECH SPACE
60
Mr Christiaan Engstrom
President, Cell Culture Company
BIOSIMILARS ARE
OPENING UP NEW
OPPORTUNITIES
BIORESEARCH
BioSpectrum takes a look at the opportunities that wearables offer for the
healthcare sector and how this technology can become an indispensable part of the
healthcare system.
WIPE HEALTH WOOS WITH WEARABLES46
EMERGING NEW WAVE OF
THERANOSTICS
A combination of diagnosis with
therapy geared to revolutionize
and disrupt the world of
healthcare diagnostics

BioContents
BIOANALYSIS
IS INDIAN HEALTHCARE READY FOR
BIG DATA ANALYTICS?
25
LUNG CANCER BURDEN OF ASIA57
BIOCOLUMN
20TH ANNIVERSARY OF THE
GLOBAL COMMERCIALIZATION
OF GM CROPS
36
Clive James
Founder and Emeritus Chair, ISAAA
BIOPRENEUR
FIB-SOL Team -- (L-R) Mr N K Gokul, Mr Anant Raheja, Dr Kavitha
Sairam Ms G Saranya)
‘BELIEVE AND TAKE
THE LEAP OF FAITH’
62
ANATOMIZ3D Team – (L-R) Mr Sohrab Kothari, Mr Sagar Shah,
Ms Shruti Kale, Mr Samkit Shah, Mr Ameeth Deshpande, Ms Firoza
Kothari
ANATOMIZING 3D PRINTING65
BioSpectrum tries to find out how the ‘Make in India’
campaign has affected the pharma and medtech sector.
‘MAKE IN INDIA’ IMPACT ON
BIOSCIENCES SECTOR
31
https://twitter.com/BioSpectrumMag
facebook.com/BioSpectrumMagazine
bit.ly/BS-LinkedIn
To subscribe online, visit http://bit.ly/1YZEMil
Or call Srinivas Rasoor +91-9845039237
www.biospectrumIndia.com

BioEdit
T
he Narendra
Modi govern-
ment has given
something for the
national biotech
sector to smile in
April 2016. A five-year wait to
set up the country’s first Inter-
disciplinary University for Life
Sciences and Biotechnology has
borne fruit under Mr Modi’s
leadership on April 26, 2016.
This historic occasion happened
when the Regional Center for Biotechnology
(RCB) Bill 2016, piloted by Minister for S T,
Dr Harsh Vardhan, was approved by the Lok
Sabha on that day. RCB, currently functioning
from a 200-acre campus as part of the Biotech
Science Cluster in Faridabad in the National
Capital Region (NCR) has been functioning on
the basis of an executive order since June 2010.
Set up in collaboration with the United Na-
tions Educational, Scientific and Cultural
Organization (UNESCO), RCB will be an in-
ternational facility open to citizens of all the
countries in India’s neighborhood to develop
highly trained human resources in biotech-
nology. The Parliamentary approval process
will be complete when the upper house (Rajya
Sabha) too gives its approval to the legislation.
The legislative approval grants the status of
an institution of national importance to RCB,
set up at a cost of Rs 100 crore that can grant
degrees directly to students. Currently there
are hundreds of life science departments in
universities and a large network of public and
private research centers that are affiliated to
various universities. RCB will be the first uni-
versity dedicated only to biotechnology. The
private Shoolini University of Biotechnology
and Management in Himachal Pradesh has its
footprint restricted to only the state.
In a relatively short period, students and facul-
ties of RCB have made a mark, winning many na-
tional laurels. RCB will now be able to showcase
India’s expertise in biotechnology to the world
and also take up a lot more inter-disciplinary
activities that involve people in areas such as-
nanotech, vaccine development, implantable
devices, diagnostics and stem cell biology.
The RCB Bill was introduced in the Lok Sabha
in 2011 but it was not taken up for discussion
and lapsed with the dissolution of the House
in 2014. In December 2015, the Modi govern-
ment approved a revised RCB Bill and apart
Parliamentary approval has come in just four
months. This is certainly a demonstration of
the government’s commitment to finally fulfil
an international obligation given to UNESCO
10 years ago when the UN agency approved
setting up this center in India.
Of course, the biotech industry will be more
happy when the long pending legislation to set
up a single biotech regulatory authority also gets
the Parliamentary approval. The Biotechnology
Regulatory Authority of India (BRAI) Bill, sent
to Parliament for approval in August 2011, has
lapsed. The Modi government has not so far re-
vealed its stand on sending a revised version of
it for Parliamentary approval. Various govern-
ment agencies are currently studying a volumi-
nous 2,000-page note on its pros and cons.
There is also a talk of junking the bill in its
present form and incorporate its provisions
in various existing legislation as the single
biotech regulatory agency concept has been
opposed vehemently by many civil society or-
ganizations. Also the wranglings between vari-
ous ministries on who will be the administra-
tor too has not been resovled.
More twists and turns could be expected in the
BRAI bill saga in the near future. BS
Narayanan Suresh
Group Editor
narayanan.suresh@mmactiv.in
I ndia gets firstbiotech university

Vol 14; Issue 4; April 2016
BioSupplier Technologies
The coverage of recent innovations and BioSupplier tech-
nologies that are helpful in expediting the drug discovery
was informative. It was interesting to read about the latest
tools and technologies available in the market to help re-
searchers on the path of drug discovery.
The articles were very useful and many of them suggest
novel solutions. Looking forward to more informative ar-
ticles in the future.
Anshul Khandelwal, Mumbai
Wrong numbers
This is with reference to the online news story on Bio-
Spectrum India website, ‘POC diagnostics market to rise
to $3 bn by 2021.’ I respectfully disagree to the forecast
claimed as above, because we are working in POCT indus-
try, and know the challenges associated with penetrating
the healthcare field, and resistance to pay premium of
instant, reliable, diagnostics report.You may contact me
and I would be happy to providemore details.
Tushar Barad via website
Interesting interviews
Your interview with 2016 Padma Awardees in sciences in
the April issue covered important areas of research status
in India. Research in India is quite far behind countries
like China, the US and the UK. Research should be en-
couraged and we need to have quality researchers. Also,
scientists mentioned lack of proper funding.
We need to address that and make science a lucrative ca-
reer choice, so as to attract more talent in this field.
Somehow, science has lost its sheen to more rewarding
careers like IT.Overall,Ifind the interviews very inspiring
and made forvery engaging read.
Shivi Jain, Bhopal
BIOSPECTRUMLATESTBIOSUPPLIERTECHNOLOGIESAPRIL2016
Volume 14  Issue 4  April 2016 www.biospectrumindia.com
An Publication
`100
India’s
trillion-dollar
opportunities
in ICT, IoT
LATEST
BIOSUPPLIER
TECHNOLOGIES
LATEST
BIOSUPPLIER
TECHNOLOGIES
LATEST
BIOSUPPLIER
TECHNOLOGIES
BIOTALK
Padma Shri
Awardee,
Prof. Dipankar
Chatterji
BIOTALK
Padma Shri
Awardee,
Prof. Veena
Tandon
BIOTALK
Padma Bhushan
Awardee,
Dr Alla Venkata
Rama Rao
ARTICLES BY
THE INDUSTRY CAPTAINS
Vol 14; Issue 5; May 2016
Publisher: Jagdish Patankar
Editorial
Chief Editor: Narayanan Suresh
Executive Editor: Srinivas Rasoor
Senior Correspondent: Raj Gunashekar
Production
Assistant Editor: Ajay Ghatage
Sub-Editor: Ayesha Siddiqui
Design
Design: Shihab KA
Sales and Marketing
AVP - Sales Marketing
Gurunath S Angadi
Sr Manager Sales: Vikas Monga
Asst Manager (Digital):
Priyamvada Bhide
Sr. Product Executive: Pavana Praveen
Print Circulation
GM, Print Services: T Srirengan
Audience Service: Sarita Shridhar
(E-mail:
biospectrumindia@cybermedia.co.in)
Press Coordinator: Harak Singh
Bangalore
MM Activ Sci-Tech
Communications
#9, UNI Building, Thimmaiah
Road, Millers Tank Bund,
Vasanthnagar,
Bangalore - 560 052
Tel.: +91-80-41131912/13
Mumbai
MM Activ Sci-Tech
Communications
133, Kaliandas Udyog Bhavan,
Babasaheb Woralikar Marg, Near
Century Bazaar,
Mumbai - 400 025
Tel. No: +91 22 2438 5007/8/9
Pune
Avinash Gulgule
MM Activ Sci-Tech
Communications
Ashirwad, 36/A/2, S.No. 270,
Pallod Farms, Near Bank of
Baroda, Baner Road,
Pune- 411045
Tel. No: +91 20 2729 1769
New Delhi
MM Activ Sci-Tech
Communications
103-104, Rohit House
3, Tolstoy Marg, Connaught Place,
New Delhi - 110 001
Tel. No: +91 11 4354 2737
Hyderabad
Y V L N Murthy
MM Activ Sci-Tech
Communications
Flat 205, Sai Sharmistha
Residency, Springfields
Colony, Jeedimetla Village,
Hyderabad-500055, Telangana
State Mob: +91 9246577114
Chennai Kerala
Krishna Kumar V
MM Activ Sci-Tech
Communications
Magattuparampil House, 1st Floor,
Lakshmi Nivas, Kannankulangara
Kidangu Road, Thrippunithura,
Eranakulam,
Kerala, Pin:682301
Tel: +91 484 2777997
Mob: +91 9526 44 3331
INTERNATIONAL
Singapore
Manager Admin Sales
Support: Saradha Mani
#14-06, High Street Centre,
1 North Bridge Road, Singapore -
179094
Tel: +65-63369142
Fax:+65-63369145
USA
Media Representative:
Ms Leslie Hallanan
Avani Media Inc., 80 Liberty Ship
Way, Suite 25, Sausalito,
CA 94965 USA
Tel.: +1-415-3312150
E-mail: info@avanimedia.com
Europe
Media Representative:
Mr. Stuart Smith
Global Media Sales Limited
PO BOX 1126, Bromley, Kent, BR1 9TX
United Kingdom
Tel: +44-(0)20-8464-5577
E-mail: stuart.smith@
globalmediasales.co.uk
Printed and published by
Jagdish B. Patankar on behalf of
MM Activ Sci-Tech Communications Pvt Ltd
Printed at Rakesh Press, A-7 Naraina Industrial
area, Phase II, New Delhi - 110 028 and
Published from 103-104, Rohit House,
3 Tolstoy Marg, Connaught Place, New Delhi - 110 001
Editor: N Suresh
Website: www.biospectrumindia.com
Our Offices - Editorial and Business

91-22-41515151 / 41515111
info@nilsan-nishotech.com
janhavi@nilsan-nishotech.com
Nilsan Nishotech Systems Pvt Ltd
Plot No. -199E,MIDCThane Belapur Road,
Khairane, Navi Mumbai 400 705

BioTalk
L
ocated in Bangalore and Maryland, USA,
EMMES Services, a contract research orga-
nization, set its foot in India in 2006, with
a mission to contribute to India’s public
health challenges and the clinical research
as a whole.
The company is backed by strongly skilled professionals
including statisticians, epidemiologists, biomedical sci-
entists, data management and information technology
professionals, and support personnel, who are necessary
to initiate and complete all aspects of clinical projects.
“In 2006 the clinical research environment was very dif-
ferent. Eighty percent of our work in the US are through
BioTalk
Though the clinical research industry
in India has been, and is going through
tumultuous ordeal, Dr Anne Lindblad,
director, EMMES, says that it hasn’t
impacted her organization as much as
other CROs.
We have no plans
to leave India

BioTalk
national institutes of health. Often they carry out global
trials, and sometimes in partnerships and collaborations
with biotech companies and the industry, or at times on
their own. Now, things have changed in India. But having
an India office has helped us even in the US. We would
like to create relationships with people that will be long-
term, and show our value by working along with them,”
explained Dr Anne.
“It is an unfortunate occurrence. Things can be much
more streamlined. The population here still has public
health needs and requires access to medicines. I’m con-
fident that as we move forward things will work through,
and again we’ll be able to have clinical trials in India more
efficiently through the regulatory process,” she added op-
timistically.
Pulling out of India
The change in the regulatory process is an essential re-
quirement as it has big effects on CROs. As a result of
unclear, stringent and impractical regulatory guidelines,
many CROs pulled out their operations out of India, and
others moved to Eastern Europe and different countries
which have simplified clinical research regulations.
“We have no plans to move our operations to other coun-
tries. We feel that India is an important place to stay. We
think that, besides pharma, there is potential opportu-
nitiesin helping physicians at hospitals, addressing pub-
lic health issues, learning risk factors for diseases in the
country and improvising care. It’s a matter of time. We
are not trying to become the biggest CRO in India, but
rather, we want to be the most important, and improve
the health scenario in India,” Dr Anne asserted.
Numerous CROs have also knocked on the doors of China
because of its simplified regulatory process.
“Middle Eastern Europe is another place where people
are researching in this area. India is working on its own
regulations and when it is complete, it will be much eas-
ier.We understand it is going to take a long time and we
are here for long-term. Even in this regulatory situation,
we can still contribute to hospitals for pragmatic stud-
ies that may help understand risk factors, improve public
health, and how it impacts the outcomes of the patients,”
she stated.
Clear regulatory path
She held that a more pragmatic approach is what will
propel the future. “It should all come back to a rational
approach with proper monitoring ensuring human sub-
jects are protected appropriately for the research that
they are volunteering to do,” she remarked.
According to her observation, providing a very clear
guidance in how to get through the regulatory hurdles to
launch a trial seem to change frequently in India.
Despite the looming uncertainties, she confidently
voiced, “Soon we are hoping that this will become clear
to companies as to what needs to be done, or even chart
out the steps needed to be taken by national institutes
in the US to partner, so that it is a fair and plain field for
We feel India is an inportant
place to stay. Besides
pharma there is potential
opportunities in helping
physicians at hospitals
Dr Anne Lindblad
director, EMMES

BioTalk
everybody.”
Most CRO clients’ hope to get assisted in terms of getting
through the regulatory hurdles.
“That’s a challenge for any CRO because the rules here
keep changing,” Dr Anne noted. “Our strength is that
we have a very strong root in biostatistics and analysis.
Armed with that, we can help various organizations in In-
dia for consulting, analysis, providing publications with
data from India, and provide directions for the next steps
in healthcare.”
Entrepreneurs innovators
The company’s clients in India are a mix from biotech
firmstomid-sized pharma organizations. It has also
worked much with government agencies, both in the US
and India.
As for EMMES, collaboration, certainly, is one of its im-
portant goals. “We are ready to carry out clinical trials
or research, which could be alongitudinal study or obser-
vational, and not just about getting drugs approved,” Dr
Anne said.
EMMES, in the US, has been around for 38 years, and
has carried out over a 1,000 clinical trials in 40 different
countries in multiple disease areas. It directly works for
12 of the 27 national institutes of health in the US.
Dr Anne has visited Indian incubators and is impressed-
by the country’s investments in young budding entrepre-
neurs with great ideas. “That’s an area where we can work
along with those entrepreneurs in developing their ideas
further. One of things that would make India a leader is
the support of entrepreneurs and innovators in the bio-
sciences,” she emphasized.
Research in US vs India
Hailing from a rich experience in the US, Dr Anne noted
that the funding mechanism in India is different from
what it is in the US.
“In the US, there is government funding, and it is very
clear as to how to gain access to those fundings. The
amount of fundings available for public agencies in India
is very less. The regulatory environment further bolsters
the hurdles. So funding and regulatory are very much
a big differentiator between the two countries. Thus,
launching a trial in India is tougher than in the US,” she
stressed.
India has a great diversity of population, not only in terms
of genetics, but also in access to care and information,
both at patient level and physician level. She observed
that a lot is being done in India to create centers of excel-
lence to train investigators on evidence-based approach
as they gear to tackle health problems in India.
“In the US too, we haven’t solved the same problems
completely either. But in India it is at a different scale.
I’m very encouraged to see how much the government is
taking interest in trying to improve in these areas. And
we want to be a part of these developments,” Dr Anne
opined.
Growth drivers
Dr Anne highlighted that EMMES, unlike other CROs, is
not driven by randomized clinical trials.
“What drives us is carrying out research that has results,
and can be published in scientific literature that will
change practice. When the regulatory hurdles in India
changes, other CROs are going to come back here, but we
are going to stay the same and our mission is not going
to change. Our drivers will be the investments that India
is putting into entrepreneurs and innovators. Regulatory
should see to find a proper balance in patients’ safety, and
yet not shutting enterprises, which we have witnessed in
the last few years,” she said.
“Getting to be known is a major challenge,” she said while
speaking about market entry challenges in India. “It has
been 9 years in India, and we are getting to know the
challenges. The challenge are getting a foot-in-the-door.
This will improve and we’ll gain momentum as we work
in India.”
Dr Anne expressed her excitement about the opportuni-
ties in India and her organization’s role in contributing
to its public health. “Our future plans are organic, and to
meet as many like-minded institutions and researchers
to develop relationships, and enable our staff to do more
that will impact the Indian population. That’s our mis-
sion and goal,” she ended. BS
Raj Gunashekar Ayesha Siddiqui
Our future plans are organic,
and to meet as many like-
minded instutions and
researchers to develop ties

BioNews
New threat against
affordable medicines
in trade negotiations
Access to affordable medicines could be severely restrict-
ed for millions of people around the world under the cur-
rent proposals in the Regional Comprehensive Economic
Partnership (RCEP) trade agreement,the international
humanitarian medical organization Médecins Sans Fron-
tières (MSF) warned.
“Proposals in the RCEP negotiations are trying to intro-
duce intellectual property measures far tougher on access
to medicines than what is required under international
trade rules”, said Ms Leena Menghaney, South Asia Head
of MSF’s Access Campaign.“If accepted, the agreement
would restrict access to affordable generic medicines for
peoplein many countries that will be part of the agree-
ment-including Indonesia, Thailand, Myanmar, Cambo-
dia and Laos - and for the millions of people around the
world who rely on lifesaving affordable generic medicines
from India.”
“Many of the intellectual property provisions that have
been tabled mirror those in the Trans-Pacific Partnership
agreement, considered the worst trade deal ever for ac-
cess to medicines”, said Brian Davies, East Asia Head for
MSF’s Access Campaign.’’Countries that did not join the
TPP-particularly India and key members of the Associa-
tion of Southeast Asian Nations (ASEAN)-will be pushed
to adopt similar standards in the RCEP negotiations.”
Themeasures that would harm access to affordable medi-
cines are all the more concerning given India is one of the
countries included in the RCEP negotiations. India - of-
ten known as the ‘pharmacy of the developing world’ for
its wide-scale production of generic medicines-supplies
life-saving affordable medicines needed to treat commu-
nicable and non-communicable diseases in developing
countries.
Two-thirds of all the drugs MSF purchases to treat HIV,
TB and malaria are generic medicines from India.
BioNews
Biotech/GM crops planted
on 2 billion hectares
from 1996 to 2015
International Service for the Acquisition of Agri-Biotech
Applications (ISAAA) released its annual report detail-
ing the adoption of biotech crops,” 20th Anniversary of
the Global Commercialization of Biotech Crops (1996-
2015) and Biotech Crop Highlights in 2015,” showcasing
the global increase in biotech hectarage from 1.7 million
hectares in 1996 to 179.7 million hectares in 2015. This
100-fold increase in just 20 years makes biotechnology
the fastest adopted crop technology in recent times, re-
flecting farmer satisfaction with biotech crops.
Since 1996, 2 billon hectares of arable land - a massive
area more than twice the landmass of China or the United
States - have been planted with biotech crops. Additional-
ly, it is estimated that farmers in up to 28 countries have
reaped more than $150 billion in benefits from biotech
crops since 1996. This has helped alleviate poverty for
up to 16.5 million small farmers and their families annu-
ally totaling about 65 million people, who are some of the
poorest people in the world.
“More farmers are planting biotech crops in developing
countries precisely because biotech crops are a rigorous-
ly-tested option for improving crop yields,” said Clive
James, founder and emeritus chair of ISAAA, who has
authored the ISAAA report for the past two decades. For
the fourth consecutive year, developing countries planted
more biotech crops (14.5 million hectares) than industri-
alized countries.

BioNews
SAGE issues recommendations to WHO for using dengue vaccine
The SAGE advises that countries with
high dengue transmission consider
introduction of the dengue vaccine as
part of an integrated disease preven-
tion strategy including vector control
to effectively lower their dengue dis-
ease burden.
Successful introduction of dengue im-
munization alongside other preven-
tion efforts should help endemic coun-
tries to achieve the WHO objectives to
reduce dengue morbidity by 25% and
mortality by 50% by 2020.
“We welcome these recommendations
for Dengvaxia from SAGE, the advisory
group to the WHO, for vaccines and
immunization,” said Dr Elias Zerhouni,
MD, President of global RD, Sanofi.
“Dengvaxia has been approved in four
countries already, including Mexico
and Brazil, which have regulatory au-
thorities recognized by WHO. These
WHO SAGE recommendations further
validate the scientific and medical value
of Dengvaxia and send a clear message
to endemic countries about the strong
public health benefit to be gained by
introducing the dengue vaccine in in-
tegrated disease management efforts to
combat their dengue burden.”
Dengvaxia vaccine’s anticipated im-
pact on dengue fever disease burden
is expected to stem from the vaccine’s
proven ability to prevent 8 out of 10
dengue hospitalizations and up to 93%
of severe dengue cases -- including
dengue hemorrhagic fever -- in study
participants 9 years and older, as dem-
onstrated during 25 months of follow-
up of phase III efficacy studies.
Healthcare sector to reach
over $280 bn by 2025
NATHEALTH, Healthcare Federa-
tion of India, an apex body for the
healthcare sector partnered with De-
loitte to present imperatives and de-
velop recommendations for actual-
izing ‘Make in India’ for the medical
devices industry and released ‘Code
of Ethics’ in collaboration with In-
dian Medical Association (IMA).
“The healthcare sector is expected to
reach $145 billion by 2018 and over
$280 billion by 2025. Though India’s
healthcare sector has evolved signifi-
cantly in the last decade,challenges
exist in providing access to quality
healthcare in the country,” saidAn-
jan Bose, secretary general, NA-
THEALTH.
“Lower financing and expenditure
on healthcare, inadequate healthcare
infrastructure and dual diseases bur-
den are key challenges faced by the
sector,” addedBose.
Medical technology cost in setting up
a tertiary care hospital amounts to
30-40 percent. Cost of medical tech-
nology/equipment/devices is 20-25
percent of total healthcare cost for a
patient.
“Given the increasing demand for
healthcare and the critical role of
medical devices in providing afford-
able and accessible health, the time
is right to align the eco system to
view medical devices as a strategic
driver. The ‘Make in India’ initiative
is the perfect opportunity to create a
step change in Indian healthcare and
especially in the medical devices in-
dustry,” said MsCharu Sehgal, part-
ner and Life Sciences and Healthcare
Leader, Deloitte India.
The medical devices market is esti-
mated to grow organically at 15 per-
cent to $8.6 billion by 2020. Though
the current domestic medical devices
market represents only 1 percent of
the global market, India is among
the top 20 in the world and among
the top 4 in Asia (after China, Japan,
South Korea). The medical devices
market has grown at 10 percent in
the past decade and is expected to
have an organic growth of 15 percent
in the medium-term against global
industry growth of 4-5 percent,” in-
formed Sushobhan Dasgupta, presi-
dent, NATHEALTH.
Industry estimates that India’s medi-
cal devices market has the potential
to become $50 billion industry by
2025 when the contribution of India
to the incremental medical devices
industry growth would become sub-
stantial at 31 percent.

BioNews
Sun Pharma receives FDA approval for BromSite
SunPharma has announced that one of its wholly owned
subsidiaries has received approval from USFDA for its
New Drug Application (NDA) related to BromSite (brom-
fenac ophthalmic solution) 0.075% for the treatment of
postoperative inflammation and prevention of ocular
pain in patients undergoing cataract surgery.
BromSite is the first non-steroidal anti-inflammatory
drug (NSAID) approved by the USFDA to prevent pain
and treat inflammation in the eye for patients undergoing
cataract surgery; other NSAIDs in this class are currently
indicated for the treatment of inflammation and reduc-
tion of pain.
BromSite developed by InSite Vision, is the first brom-
fenac ophthalmic solution formulated in DuraSite, a
polymer-based formulation that can be used to improve
solubility, absorption, bioavailability, and residence time
as compared to conventional topical therapies.
Sun Pharma acquired InSite Vision in November 2015
and is likely to commercialize BromSite through its newly
formed, US-based division, Sun Ophthalmics, in the sec-
ond half of 2016.
Sun Ophthalmics has crossed a key business milestone
through BromSite’s approval. Sun Ophthalmics targets
to provide eye care practitioners products that enhance
their practice patterns and treatment options and to de-
liver those products through its unique, concierge level
approach to customer care.
With BromSite’s approval and additional late-stage can-
didates in its pipeline, Sun Ophthalmics is strongly posi-
tioned to offer a range of beneficial products and estab-
lish itself as a respected and trusted partner.
“Over the years, I’ve worked closely with the InSite team
and watched them develop multiple high quality products
using the DuraSite platform,” commented Dr Richard L
Lindstrom, MD, founder and attending surgeon of Min-
nesota Eye Consultants and Adjunct Professor Emeritus
at the University of Minnesota Department of Ophthal-
mology.
Sanofi invests €300 million to expand
biologics site in Belgium
The investment in Geel, Belgium, fur-
thers Sanofi’s commitment to driving
the future of biologics by expanding
manufacturing and commercial ca-
pabilities in order to ensure quality,
capacity, and scale.
Through the investment, Sanofi
plans to adapt and expand existing
production capabilities to support
Sanofi’s pipeline of monoclonal an-
tibodies.
Updates to the existing facility will
include the development of new lab-
oratories focused on quality control
and manufacturing sciences.
“This investment not only strength-
ens our goal of becoming a leader in
biologics but represents our focus on
patients’ needs,” said Philippe Lus-
can, Executive Vice President, Global
Industrial Affairs and President of
Sanofi in France. ‘‘We have a robust
development pipeline of biological
molecules, including monoclonal
antibodies, and this investment fur-
thers our work and expertise in key
disease areas such as cardiovascular
disease, rheumatoid arthritis, and
atopic dermatitis. This is an exciting
opportunity for our site in Geel and
we are very pleased with the support
we received from the Government of
Flanders, the Flanders Investment
and Trade and the Flanders Entre-
preneurship agency.”
Sanofi and its specialty care global
business unit, Sanofi Genzyme, have
already invested €600 million in the
Geel site, which began industrial bio-
tech activities in 2001.
The site is currently responsible for
the global production of a protein
therapy for Pompe disease, a rare,
genetic muscular disease that is of-
ten fatal.
The protein therapy is produced us-
ing cell cultures in large bioreactors,
followed by a purification process.

BioNews
Merck Animal Health
to acquire rights to
Whisper Veterinary
Stethoscope System
Merck Animal Health (known as MSD Animal
Health outside the United States and Canada)
has announced plans to acquire worldwide
rights for the Whisper Veterinary Stethoscope
System from Minnesota-based Geissler Com-
panies.
The Whisper Veterinary Stethoscope System is
a Bovine Respiratory Disease (BRD) detection
system which is used to determine the severity
of an animal’s lung condition so that the ap-
propriate treatment regimen can be started to
protect the health of the animal.
Bovine Respiratory Disease is the most com-
mon disease affecting cattle in North America.
This complex, multi-factorial infection affects
the upper and lower respiratory tracts and can
often be fatal, causing billions of dollars in eco-
nomic losses for farmers. Identifying the cause
of the disease and appropriate treatment path-
ways is vital to maintain an infected herd.
“We are pleased to add the Whisper Veteri-
nary Stethoscope System to our comprehensive
portfolio of vaccines and pharmaceutical prod-
ucts for the cattle industry,” said Rick DeLuca,
President, Merck Animal Health.
‘‘It is important to provide our customers with
the most innovative solutions available today
that will meet their needs to maintain healthy
stock and advance animal well-being.”
Orchid receives FDA nod for
Rasagiline generic formulation
Chennai-based Pharma major, Orchid Pharma, has received final
approval from the US FDA for its ANDA (Abbreviated New Drug
Application) for Rasagiline Tablets 0.5 mg and 1 mg. This product
is a FTF (First-to-file) application with a shared 180-day exclusiv-
ity for Orchid.
Orchid expects to launch this product in Q4 of FY 16-17. Rasagiline
Mesylate Tablets are indicated for the treatment of the signs and
symptoms of idiopathic Parkinson’s disease.
With a market size of over $300 million and limited generic com-
petition, Orchid hopes to garner a decent market share from this
product launch.
Pfizer terminates proposed
merger with Allergan
Pfizer has announced that the merger agreement between Pfizer
and Allergan has been terminated by mutual agreement of the
companies. The decision was driven by the actions announced by
the US Department of Treasury on April 4, 2016, which the com-
panies concluded qualified as an ‘Adverse Tax Law Change’ under
the merger agreement.
“Pfizer approached this transaction from a position of strength
and viewed the potential combination as an accelerator of existing
strategies,” stated Ian Read, chairman and chief executive officer,
Pfizer. “We remain focused on continuing to enhance the value of
our innovative and established businesses. Our most recent prod-
uct launches, including Prevnar 13 in Adults, Ibrance, Eliquis and
Xeljanz, have been well-received in the market, and we believe our
late stage pipeline has several attractive commercial opportuni-
ties with high potential across several therapeutic areas. We also
maintain the financial strength and flexibility to pursue attractive
business development and other shareholder friendly capital al-
location opportunities.”
“We plan to make a decision about whether to pursue a potential
separation of our innovative and established businesses by no lat-
er than the end of 2016, consistent with our original timeframe for
the decision prior to the announcement of the potential Allergan
transaction,” continued Read. ‘‘As always, we remain committed
to enhancing shareholder value.”
In connection with the termination of the merger agreement, Pfiz-
er has agreed to pay Allergan $150 million for reimbursement of
expenses associated with the transaction.

BioNews
Lupin to market Novartis’
inhaler in India
Pharma major Lupin and Novartis Healthcare
(NHPL) have entered into a co-marketing agreement
to promote Novartis’s Indacaterol/Glycopyrronium
110mcg/50mcg inhaler, a treatment for chronic ob-
structive pulmonary disease (COPD) under the brand
name of Loftair.
Lupin would be using its own specialty field force to
promote Loftair inhaler. NHPL will continue to market
Indacaterol/Glycopyrronium 110mcg/50mcg inhaler
under its brand name Sequadra through its own sales
force.
Loftair is a fixed dose combination of two bronchodi-
lators: Indacaterol maleate, a long-acting beta2-adren-
ergic agonist (LABA) and glycopyrroniumbromide, a
long-acting anticholinergic (LAMA) for the treatment
of COPD. The once daily Indacaterol/Glycopyrronium
combination significantly reduced the rate of moderate
or severe exacerbations by 31% compared to the current
standard of care (SFC twice-daily salmeterol + flutica-
sone combination) in patients with moderate-to-severe
chronic obstructive pulmonary disease.
This combination has also shown superior efficacy
vs SFC (salmeterol/fluticasone) for lung function,
breathlessness (assessed using the Transition Dys-
pnea Index), health-related quality of life (measured
using the St George’s Respiratory Questionnaire) and
on-demand (rescue medication) salbutamol use. Inda-
caterol/Glycopyrronium combination is approved for
use in COPD in 82 countries including US, EU, Japan,
Canada, countries within Latin America and Australia.
The agreement helps address the growing incidence of
COPD, by making better treatment options available to
patients in India.
Announcing the agreement, Shakti Chakraborty, group
president, India Region Formulations, Lupin said, “We
at Lupin are excited about the expansion of our ongo-
ing partnership with Novartis Healthcare Private Lim-
ited (NHPL) for the Inhalation/COPD segment. We had
previously entered into a similar agreement with NHPL
to market Onbrez. We are confident that this partner-
ship for Loftair will enable us to further consolidate and
strengthen our market leadership within the Indian
COPD, Anti-Asthma, Inhalation therapy segments.”
Illumina files patent
infringement suit
against Genoma SA
Illumina has announced that it, and its wholly owned
subsidiary, Verinata Health (together Illumina), filed a
patent infringement suit against Genoma SA in the Fed-
eral Patent Court in Switzerland. Illumina is seeking all
available remedies, including damages and injunctive
relief.
The patents asserted are European Patent (CH) 2 183
693 B1, European Patent (CH) 0 994 963 B2, European
Patent (CH) 1 981 995 B1, and European Patent (CH) 2
514 842. The patents are directed to using cell-free fetal
DNA for non-invasive prenatal testing (NIPT).
The suit accuses Genoma’s Tranquility NIPT testing ser-
vice, including its use of next-generation sequencing to
analyze cell-free DNA from a sample of maternal blood.
Genoma’s testing facility in Switzerland also services
samples collected from its other labs, including those
located in Spain and Italy.
“We will continue to monitor activities in the NIPT field
and file suits where appropriate to protect our substan-
tial investments in this technology covered by our intel-
lectual property,” said Charles Dadswell, Senior Vice-
President and General Counsel for Illumina.
The Tranquility NIPT service uses the IONA Test sold
by Premaitha Health. Illumina previously filed separate
suits against Premaitha in the United Kingdom for sale
of the IONA Test.

CoverStory
CoverStory Raj Gunashekar
Imagine a very tiny capsule injected
just below the skin of your arm.
The capsule has a sensor
capable of continuously
measuring blood glucose
levels and sends the
information to your
phone. Well, let’s spice
it up one level above the
notch. Say, when the blood
glucose level crosses its
threshold, visualize the tiny
little capsule releasing a dose of
insulin in your blood stream. What
this does is offer total freedom from
regular needle pricks to measure blood sugar
levels, and frees patients from the anxiety of
taking the right insulin doses at the right time.
EMERGING NEW WAVE OF
THERANOSTICS

www.kromasil.com
Kromasil ClassicShell
Expanding opportunities
Kromasil ClassicShell columns are
based on solid-core particles and
intended for the analysis of sample
mixtures in various areas of
research as well as quality control
in pharmaceutical, environmental,
food and beverages and industrial
laboratories.
AkzoNobel / Kromasil
Separation Products, SE445 80 Bohus, Sweden,
tel: +46 31 58 70 00, email:
kromasil@akzonobel.com
C Abhaykumar Co.
117, Hindustan Kohinoor Indust. Co
L B S Marg, Vikhroli (W)
Mumbai 400083 (India)
tel: +91-22-40764-700/701
email: cabhay@bom3.vsnl.net.in
Shreetech Associates
156/5120 Prasad
New Tilaknagar, Chembur,
Mumbai 400089 (India)
tel: +91-22-6522 5762
email: shreetech.associates@gmail.com
Our authorized partners in India:

CoverStory
SCIENCE FICTION
OR REALITY?
Nope, this isn’t something straight
out of a Steven Spielberg’s upcoming
science fiction movie. This is Ther-
anostics. A combination of diagnosis
with therapy geared to revolutionize
and disrupt the world of healthcare
diagnostics.
“The idea of Theranostics is old,” says
Dr Biplab Bose, an Associate Profes-
sor in the Department of Biosciences
and Bioengineering at the Indian
Institute of Technology (IIT), Guwa-
hati. “However, the term was coined
and gained popularity in recent
times, thanks to the development of
targeted drug-delivery, microfluid-
ics, and nanotechnology. Both in In-
dia and abroad, extensive work is go-
ing on to use targeted nano-delivery
systems for Theranostics. A prime
focus on this is to create drug loaded
nanoparticles that are suitable for
both in-vivo imaging and as well as
for targeted drug-delivery.”
Theranostics is the development and
use of molecules for both diagnostics
and therapeutic purposes, thereby
providing precision medicine to pa-
tients first in a clinical setting for fur-
ther understanding their diseases at
molecular level, and then prescribing
specific medicines.
“For example,” adds Dr Aman Shar-
ma, the Founder of Pune-based start-
up ExoCan Healthcare Technology
which focuses on Oncodiagnostics and
Therapeutics space, “fever in different
patients has similar symptoms like
rise in the body temperature. Howev-
er, it may occur due to different infec-
tions. Hence, detecting the infection,
whether bacterial or virus, accurately
and then providing specific therapy is
addressed by Theranostics.”
The classic example is the use of Her-
ceptin drug, a monoclonal antibody
(mAb), against HER2 receptor, a
specific protein expressed in almost
30% of breast cancer patients, to
treat grade IV breast cancer patients.
Theranostics approach would be to
first identify HER2 over-expression
in breast cancer patients by a diag-
nostic test, and then prescribe Her-
ceptin as a drug to those who have
this over-expression.
In other words, Theranostics deliver
customized treatment plan for pa-
tients, resulting in the availability of
right drug, for the right patient, at
the right time.
“This combining of therapeutic and
diagnostic modalities for personal-
ized treatment of patients enhances
drug efficacy and ensure patients
safety,” comments Dr Arumugam
Muruganandam, MD CSO of Ban-
galore-based Affigenix Biosolutions.
“At present in India, patient-centered
care which focuses on integrating
two disciplines such as imaging and
therapy for targeted drug-delivery at
the site of action is in limited prac-
tice except in specialty hospitals for
cancer and cardiovascular diseases
(CVDs).”
INDIAN
THERANOSTICS SCENE
India is yet to get its share of mod-
ern Theranostics field. There are a
few start-up companies in India that
are operating in the Theranostics and
personalized medicine in general.
“Theranostics and personalized med-
icine are very nascent sectors in In-
dia, as compared to the West, where
personalised medical approaches
have reached the clinic on a much
larger scale,” shares Dr Nilay Lakh-
kar, Founder CEO, SynThera Bio-
medical, a start-up focusing on man-
ufacturing and commercialization of
biomaterials-based medical devices.
Unfortunately, Indian
pharma companies
are slow to pick
the thread from
laboratories, and have
not yet built upon the
developments that
have happened in
academic labs…”
Dr Arumugam Muruganandam
MD CSO, Affigenix Biosolutions
Dr Nilay Lakhkar
Founder CEO, SynThera Biomedical

CoverStory
The West may be early adopters of
the evolving field of Theranostics
into their routine healthcare as it
promotes safer and more efficacious
pharmacotherapies to patients which
is supported by patients, and encour-
aged by insurance companies.
“Whereas in India, we may gradu-
ally implement Theranostics across
urban areas as it becomes affordable
with appropriate testing systems,
and expertise becomes available,” re-
marks Dr Arumugam.
Currently in the West, a severe dis-
ease like cancer is treated through
precision medicine. For example,
mutational typing of a cancer is first
performed and the right therapy or
drug is then prescribed based on the
mutation.
Considering the Indian population
and its disease burden, Theranos-
tics will eventually enter the Indian
healthcare market in a big way in the
next couple of years.
“In the next 5 or 6 years, we would see
some form of Theranostics in clinical
use, particularly for solid tumours. I
believe oncologists along with radi-
ologists will probably be the first to
introduce Theranostics in clinics,” Dr
Biplab predicts.
However, the key question is whether
India will be able to develop any such
products indigenously?
There are several lacking factors,
points Dr Biplab. “Factors include
lack of access to advanced instru-
ments. India is lacking in the de-
velopment of real-life microfluidic
devices. However, Indian scientists
have gained reputation in the field of
nano-materials, including nano-drug
delivery systems. Unfortunately, In-
dian pharma companies are slow to
pick the thread from laboratories,
and have not yet built upon the de-
velopments that have happened in
our academic labs,” he stresses.
Also, the patients in India are not
much clinically educated. “One of
the fundamental issue is cost fac-
tor, and the absence of active clini-
cal trials and proper counselling in
government hospitals; and lack of
high throughput facilities are among
many reasons which retard the de-
velopment of opportunities in Ther-
anostics in our country,” highlights
Dr Aman.
The key areas of Theranostics have
developed rapidly in the last few
years including Photo-Immunother-
apy (PIT), and nano-particle-based
drug-delivery and imaging systems.
“We may soon see some successful
clinical trials in these two segments,”
reveals Dr Biplab.
In a way, personalized medicine,
Theranostics and precision medi-
cine are all interlinked from the view
point of treatment.
Dr Arumugam explains, “It is all
about the right drug, at the right
time, for the right patients. Ther-
anostics mainly refers to treatment
strategy that combines therapeutics
with diagnostics as one treatment
unit. Personalized medicine imply
that drugs are being customized for
each individual patient. In precision
medicine, the dosing regimen is de-
signed for patients based on drugs
used, condition to be treated, ge-
netics, environmental and lifestyle
factors.”
Theranostics require
active collaboration
between academia,
clinicians and the
industry. In India such
collaborations are
rare, if not absent…”
Dr Biplab Bose
Associate Professor, Department of
Biosciences and Bioengineering, Indian
Institute of Technology (IIT) Guwahati
Dr Aman Sharma
Founder CSO, ExoCan Healthcare
Technology

CoverStory
Theranostics is important for both
personalized as well precision medi-
cine, feels Dr Biplab.
“I would say, it is important more
for precision medicine. Take the ex-
ample of a drug-delivery system that
combines targeted drug-delivery and
imaging of drug-delivery. Such drug-
delivery system would allow the phy-
sician to deliver the drug to specific
location as well as confirm it by imag-
ing,” he notes.
INDIA’S OPPORTUNITIES
AT HAND
Indian population is genetically very
diverse. Scientifically, the West-built
Theranostics tools may not work well
for Indian population.
Moreover, the mutations or genomic
anomalies present in the Western
population may not be harbored by
the Indian patients due to different
genetic makeup.
Dr Aman explains, “Hence, develop-
ment of indigenous pool of databases
for Theranostics in various diseases is
what we should start with. Three vital
opportunities lie ahead for Theranos-
tics in India. Firstly, disease-specific
database (diabetes, heart disease,
and cancer can be taken on priority)
generation for personalized medicine
by genotyping known mutations and
validation of existing biomarkers.
“Secondly, setting up minimal infra-
structure for Theranostics tests in
hospital level settings. Lastly, there
must be patient counseling centres in-
side hospitals to make patients aware
of their disease type. Economically,
we are one of the biggest markets for
Theranostics as mentioned earlier due
to very divergent genetic makeup of
the population. The government can
encourage public-private partnerships
to promote Theranostics research in
collaboration with pharma and bio-
technology giants and improve infra-
structure for such opportunities.”
For advanced diseases like cancer,
the greater diversity in Indian popu-
lation creates a window of opportu-
nities for Theranostics or precision
medicine.
Dr Nilay opines that opportunities do
exist for Indian companies to focus
on cutting-edge Theranostics prod-
ucts and services with demands be-
ing driven by a growing, affluent, and
knowledgeable patient pool.
“However, the Indian market for per-
sonalised medicine is still very much
a niche market focused on high-net-
worth individuals (HNWIs), and up-
per middle-class consumers, since
these therapies are highly expensive,
and not yet easily scalable,” he justi-
fies.
Dr Biplab believes that the first use
of Theranostics would probably be
in oncology clinics, where physicians
would use targeted drug-delivery for
solid tumours, and would be able to
image or monitor such delivery in
real-time.
“Cancer is one of the leading causes
of death in India, and its burden is
increasing. Unlike many other dis-
ease, precision medicine is crucial
in cancer. In near future, we may see
several players in cancer Theranos-
tics to enter the Indian market,” adds
Dr Biplab.
India also has vast potential to ex-
ploit the Theranostics especially in
nano Theranostics for patient care,
provided the regulation and funding
support system helps in the discovery
by academic sector; development by
biopharma sector; and adoption by
healthcare providers for personalized
treatment.
STRICT COMPETITION?
Experts believe that the real
completion is yet to begin per-
haps due to great investments
required in any Theranostics pro-
grams.
One of the reasons is that it re-
quires a huge sample base to
start with, and compilation of
information to reach statistical
end-points.
“Subsequently, that information
is then put-up into RD to de-
sign effective therapies for pa-
tients. The whole process is far
more costly than just develop-
ing a common drug which would
be used by bulk and unsorted
population. Though, the field
has far reaching implications for
mankind, it is yet to take off to
reach to its newer heights,” says
Dr Aman.
Dr Arumugam also believes that
though Theranostics has good
potential it does not have any
competition at the moment.
“In India, both doctors and pa-
tients may prefer to go with
‘one-size-fits-all’ approach, and
continue with trial-and-error
method for treating patients.
Potential impact on revenue by
the ‘slice-and-dice’ approach in
selecting patients for personal-
ized treatment will prevent wide
acceptability by bigger hospital
managements and biopharma
companies, and may resist to
change,” he emphasizes.

CoverStory
“The middle income group popula-
tion is growing in India, and medical
tourism is on the rise, and my guess
is that wealthy patients may be more
willing to pay for personalized treat-
ments,” Dr Arumugam says.
OVERCOMING
OBSTACLES
Therapy and diagnosis go hand-in-
hand, and both are expensive for a
country like India,
“Patient affordability is going to be
a big challenge,” stresses Dr Arumu-
gam. “There is also perceived loss of
opportunity by drug manufacturers
for particular drug to be used by cher-
ry-picking patients for treatments as
it reduces the market potential of the
drug. Educating doctors, patients, in-
surers and regulators will be a chal-
lenge as Theranostics does not pro-
vide guaranteed outcome yet.”
Theranostics is closely related to
patients. “Hence we should educate
more patients about their disease
types and right therapies, and how
it can enhance lifesaving chances
in case of a deadly disease,” recom-
mends Dr Aman.
There is a need for the existence of
certain private equity bodies, venture
capitalists and government schemes
who can invest in high-risk upcom-
ing areas like Theranostics.
It also calls for setting up infrastruc-
ture to create biobanks, tissue banks,
and minimal research setups in hos-
pitals and medical colleges for creat-
ing our own indigenous databases.
Dr Aman continues, “One of the most
important shortcomings is the lack
of good research in this area in our
country. The government should set
up special grants schemes to promote
biological research in Theranostics,
and should also make a provision to
bring research entities, medical col-
leges, and hospitals under one um-
brella to make the best use of existing
knowledge and resources.”
Just like drug development, work
on Theranostics requires clarity on
specific clinical requirements, under-
standing market dynamics, and the
limitations of current technologies.
“Therefore, successful development
of a Theranostics requires active col-
laboration between academia, clini-
cians and the industry. In India such
collaborations are rare, if not ab-
sent,” Dr Biplab mentions.
THE FUTURE
In longer terms, Theranostics would
pave the way for a healthier world
around us.
Advancement in nanotechnology,
biosensors, bioelectronics, pharma-
cogenetics, cancer immunotherapy,
biomarker profiling, companion di-
agnostics, and the ability to combine
therapeutic and diagnostic capabili-
ties into one single agent (nanoma-
terials) have already started a ripple
effect in healthcare.
“The only limiting factor is going to
be the affordability for personalized
treatment,” states Dr Arumugam.
In the future, patients who suffer
from chronic diseases will have a
combination of wearable devices and
implantable Theranostics.
Dr Biplab observes, “These will mon-
itor our critical health parameters in
real-time and intervene at the right
time. Considering the speed in de-
velopment of micro-fabrication and
micro-electronics, I believe, such de-
vices will be in our homes within the
next 10 years.”
Five years down the line, break-
throughs in Theranostics RD may
bring down treatment costs, and in-
crease scale-up potential.
“A focus on building strategic part-
nerships with global players in the
pharma and diagnostics sectors may
be the way forward for Indian com-
panies in this space,” suggests Dr
Nilay.
Through Theranostics, the treat-
ment costs might go up initially, but
a faster disease recovery would be
ensured.
Dr Aman voices, “Theranostics might
improve patient survival chances es-
pecially in cancer and heart disease
patients. In totality, a greater health,
emotional, and life security is what
the goal of Theranostics is.”
At the moment, India does not have
a statistical data on molecular nature
of disease(s) among the Indian popu-
lation.
Nevertheless, combining the three
major diseases including diabetes,
heart disease, and cancer, Theranos-
tics market should value anywhere
between $300-500 billion in the next
5 years. BS

BioAnalysis
BioAnalysis
The buzz word Big Data Analytics no doubt has lot of applications in healthcare
starting from basic research to clinical trials. But are lifesciences and healthcare
firms realizing the opportunities that big data brings to healthcare? And most
importantly, how relevant it is for Indian healthcare system and is our country
ready to exploit analytics in healthcare. BioSpectrum tries to find out.
IS INDIAN HEALTHCARE READY FOR
BIG DATA ANALYTICS?

BioAnalysis
Primary objective of big data analyt-
ics is to discover new knowledge from
multiple dissimilar data sources to
create actionable values that has high
impact, says Prahalad Achutharao,
Founder CEO, InterpretOmics, In-
dia’s first data sciences company that
provides state of the art genomics
software solutions to pharma, bio-
tech, CROs and healthcare organisa-
tions.
He added, “For example, which dis-
eases are co-morbid? Bangalore is
considered the breast cancer capital
of India; whereas Vidarbha is consid-
ered as the oral cancer capital of In-
dia. The answer to the question ‘why’
will require terabytes of data to be
processed that will include, genomic
data, phenotypic data, clinical data,
and of course environmental data.”
By analyzing trends and comparing
them to stored knowledge base, we
can achieve a significant number of
predictions and put in place proac-
tive disease management protocols.
“The power to access and analyze
enormous data sets can improve
our ability to anticipate and treat
illnesses better. This data can help
throw light on individuals who are at
risk for serious health problems. The
ability to use big data to identify gaps
in the healthcare system can also
lower the cost of healthcare across
the board,” says Ravi Ramaswamy,
Senior Director of Healthcare at Phil-
ips Innovation Campus (PIC).
ARE HEALTHCARE FIRMS
LEVERAGING ANALYTICS
IN HEALTHCARE?
By and large most of the firms
(healthcare and life sciences) are try-
ing to understand the potentials of
big data, however, the adoption is
still at nascent stage in India and has
been minute compared to the oppor-
tunities and potential of big data.
Healthcare sector, in general, lags
behind some other industries in us-
ing data and analytics to improve
quality lower cost.
“In life sciences, big data analytics is
a key way to translate gene sequences
into actionable genomic targets. In
healthcare services, big data analyt-
ics is used less frequently because
the uses are less well established and
because of the high cost of acquir-
ing the necessary data and technical
expertise. That said, more and more
companies see the need for big data
analytics and are making strategic
plans to incorporate it,” said Huse.
Apollo Hospitals, for example, is us-
ing big data analytics in many areas.
“We are using big data analytics for
By analysing trends
and comparing them
to stored knowledge
base, we can achieve
significant number of
predictions
Mr Ravi Ramaswamy
Senior Director of Healthcare at Philips
Innovation Campus (PIC).
POTENTIAL AND
PROMISES OF BIG DATA
The most evident and apparent ap-
plication of big data is in the area of
precision medicine, but that’s not all.
Healthcare is a very big domain and
big data has a lot of potential in how
we envisage disease.
“Apart from precision medicine,
there is optimism that big data ana-
lytics will help improve care. For ex-
ample, big data technologies have the
potential to reduce avoidable read-
missions, enable new research proj-
ects, and track patient vital statistics
in real time,” said Dan Huse, Vice-
President, MarketScan Databases
and Tools, Truven Health Analytics.
According to Dr Anurag Agrawal,
Principal Scientist, CSIR Institute of
Genomics Integrative Biology and
Associate Professor, AcSIR and Bay-
lor College of Medicine, USA, said,
“Big data analytics is relevant not
just to the personalized health man-
agement an individual patient, as is
promised by precision medicine, but
towards reinventing healthcare it-
self. For example, even the semantic
framework of medicine e.g. disease
names like diabetes, asthma etc.,
would be changed if we could see dif-
ferent clusters of risks and outcomes
within each disease.”

BioAnalysis
infection control and surveillance.
This initiative was recently recog-
nized as the winner of the 2016 –
Microsoft innovation awards. The
implementation of the analytical tool
brought the process of analysis and
clinical DSS (decision support sys-
tems) to near real time. The process
that used to typically take three weeks
is now made real-time at bedside and
available for direct clinical decision
support within the EMR,” said Ar-
vind Sivaramakrishnan, Member,
FICCI Sub-committee on Electronic
Health Record (EHR).
The value for big data in healthcare
today is largely limited to research
because using big data requires a
very specialized skill set.
The industry is still far from using
big data for commercial healthcare
applications to its full potential says
Rama Chandra Dash, Business Unit
Leader, IBM Watson Health, India
Software Lab.
He explains, “The reason being: in
the present state of healthcare indus-
try, all the 4 V’s (4 Vs volume, variety,
veracity, velocity) that defines big
data are relevant, but the industry is
swamped with some very pedestrian
problems such as regulatory report-
ing and operational dashboards.
Most just need the proverbial ‘air
and water’ right now, but once basic
needs are met and some of the initial
advanced applications are in place,
new use cases will arrive (e.g. wear-
able medical devices and sensors)
driving the need for big data style so-
lutions.”
RISK AND CHALLENGES
Healthcare is a high risk service
where life and death decisions need
to be taken and big data has its own
set of challenges.
“Companies will need to pay atten-
tion to daily operational necessities
such as security and privacy require-
ments, systems management, data
access, government regulations, en-
cryption and where necessary, data
obfuscation and de-identification.
There is a risk that companies will
invest a lot of time and money in
developing a big data analytic infra-
structure and not obtain the expected
return on investment,” said Huse.
Data transparency pose another
challenge. “Over a period of time,
India will build a staggering amount
of healthcare data but it would be
spread among hospitals, primary
care providers, researchers, health
insurers, and state and central gov-
ernments — just to name a few. Each
of these acts as a silo, preventing data
transparency across the healthcare
system,” said Ravi Ramaswami.
Perhaps the biggest challenge is to
tackle the issue of patient privacy as
data privacy in healthcare is of prime
importance.
“In addition to aggregating a massive
amount of data, there’s the challenge
of maintaining patient privacy. Fig-
uring out how to leverage that infor-
mation to deliver better quality care
to patients while keeping it secure is
a major challenge, and one that all
organizations are taking seriously,”
said Ramaswami.
Variety of data is another key chal-
lenge for big data analytics. “The
data can be structured, unstructured
or semi-structured. Deriving insights
from handwritten notes of doctors
and medical practitioners through
image recognition has a certain de-
gree of error associated with it. The
data collected from fitness gadgets,
social media research and other
sources are unstructured compared
to the data collected traditionally
Mr Rama Chandra Dash
Business Unit Leader, IBM Watson Health,
India Software lab
Mr Dan Huse
Vice President, MarketScan Databases and
Tools, Truven Health Analytics
Dr Anurag Agrawal
Principal Scientist, CSIR Institute of Genomics
Integrative Biology and Associate Professor,
AcSIR and Baylor College of Medicine, USA

BioAnalysis
by hospitals. Deriving insights from
such a variety of data is a challenge in
itself,” said Rohit Verma, CEO, iPre-
dictt. iPredictt Data Labs is a big data
analytics start-up that provides ma-
chine learning software to B2C com-
panies to solve their complex data
challenges.
Several issues will have to be ad-
dressed to capture the full potential
of big data. Policies related to pri-
vacy, security, intellectual property,
and even liability will need to be ad-
dressed in a big data world.
“Organizations need not only to put
the right talent and technology in
place but also structure workflows
and incentives to optimize the use of
big data. Access to data is critical —
companies will increasingly need to
integrate information from multiple
data sources, often from third par-
ties, and the incentives have to be
in place to enable this,” said Ramas-
wamy.
BIG DATA: HYPE OR
HOPE FOR BETTER
HEALTH OUTCOMES?
Definitely not hype and it is not a
hope any longer – it is a reality says
Dr Asoke Talukder, co-founder and
Chief Scientific Officer, Interpre-
tOmics India.
“Big data analytics is clearly a hope
for better health outcomes. The exe-
cution of the big data analytics needs
to be carefully planned and executed
in order to reach the desired out-
comes. This clearly means that the
right levels of investment of time and
effort has to be done. Mere financial
investment cannot assure results.
The quality of human resources in-
vested in this process is crucial and
must be at the right levels at every
stage of the initiative,” said Sivara-
makrishnan.
It is not a hype but everyone jumping
onto it without realizing its potential
or application is a cause for worry
says Dr Debojyoti Dhar, Founding
Member Director (Business Devel-
opment and Innovation) at Leucine
Rich Bio.
Leucine Rich Bio is a bioinformatics
driven company based in Bangalore,
India, specializing in Next Genera-
tion Sequencing (NGS) Data Analysis
Interpretation.
Big data analytics is not a hype, it en-
ables us to predict health outcomes
which gives us the opportunity to
monitor our health in better ways.
“We need big data analytics in India.
In a big country like India with such
a large population, big data enables
us to analyze and predict the health
of patients. There is acute shortage of
doctors in the country and big data
will enable us to manage our pre-
cious resources in a better and effi-
cient manner,” said Verma.
PROTECTING PATIENT
PRIVACY
Data security/privacy is of para-
mount importance for patients/
hospitals more so in case of genetic
diagnostics. How do firms utilizing
big data address that? Are there any
regulatory challenges to the usage of
patient data, yet?
“Data security/privacy is a major
concern in firms when tackling big
data. In USA, the HIPAA act and HI-
TECH Act is the cornerstone regard-
ing healthcare and regarding the data
associated with it,” said Verma.
In healthcare, HIPAA compliance is
non-negotiable agrees Dash.
He added, “Nothing is more impor-
tant than the privacy and security of
Mr Rohit Verma
CEO, iPredictt
Dr Asoke Talukder
co-founder and Chief Scientific Officer,
InterpretOmics India
Mr Prahalad Achutharao
Founder CEO, InterpretOmics India

BioAnalysis
patient data. There aren’t many good,
integrated ways to manage security
in big data. Although security is com-
ing along, it has been an afterthought
up to this point. And for good reason,
if a hospital only has to grant access
to a couple of data scientists, it re-
ally doesn’t have too much to worry
about. But when opening up access to
a large, diverse group of users, secu-
rity cannot be an afterthought.”
Security and privacy concerns are
among the highest in this industry.
Implementation of security controls
is based on multiple factors and is
put in place after assessment of the
risks, vulnerability and impact.
“Aspects that need to be taken care of
include identity management, physi-
cal security, personnel security, ap-
plication security and privacy among
others. Various security measures
that are put in place include attribute
based encryption policy that covers
Ciphertext policy ABE, Key Policy
ABE and fully homomorphic encryp-
tion. There are a lot of regulations
that drive the way cloud technologies
are deployed in respective countries.
For example, in the case of Indone-
sia and Singapore, patient data can-
not be taken out of that country. This
necessitates the Cloud providers to
have specific data centers in each of
these countries. Europe in general is
a lot more stringent when it comes
to data privacy, security and porting
across regions,” said Ramaswamy.
India does not have the appropriate
regulatory framework in place yet.
“In India, it’s Information Technol-
ogy (Reasonable Security Practices
and Procedures and Sensitive Per-
sonal Data or Information) Rules,
2011. But, these rules are generic
rules in terms of data privacy which
among others include healthcare
data. Basically, the IT Act enlists pa-
tient data under private data and re-
stricts its use,” said Verma.
The lack of specific directives for
healthcare data, is a concern for big
data firms.
INDIAN HEALTHCARE
READY FOR BIG DATA?
Indian healthcare is still in its embry-
onic stage when it comes to adopting
big data analytics.
The bigger private hospitals in the
cities use computers to store data
electronically through hospital ad-
ministration software and other use-
ful software. This enables big data in-
tegration due to large amount of data
collected.
“But, the average Indian in rural and
semi-urban areas still visit small
clinics and hospitals which rely on
paperwork. The benefits of big data
analytics will reach the masses only if
this problem is tackled,” said Verma.
“We have been using big data analyt-
ics in both genomic and healthcare
data. We have also developed big
data solution platforms – iOMICS
Research and iOMICS Clinical that
are used by globally at the bedside
and bench (research),” said Achuth-
arao.
Dr Talukder explains, “The iOMICS
Research software product takes
hundreds of terabytes of data from
DNA, mRNA, miRNA, ChIP, etc,
combine them to derive an action-
able functional insight. And iOMICS
Clinical on the other hand helps ge-
nomics to phenomics to go one step
further to solve the complex ques-
tions of pharmacogenomics and
healthcare.”
Healthcare across the globe requires
big data analytics to improve care and
reduce costs. India is no exception.
As India continues to adopt more and
more healthcare technology, more
and more big data analytics will be
possible, Huse concluded. BS
Security and privacy
concerns are among the
highest in this industry.
Ayesha Siddiqui

BioAnalysis
It’s been a little over a year (19 months, to be exact) since the PM launched his pet
project, ‘Make in India’ campaign. The topic has been talk of the town and PM’s
numerous offshore visits has also made sure that the topic is abuzz and has never
stopped trending on social media. Apart from making headlines, BioSpectrum tries
to find out how the campaign has affected the pharma and medtech sector.
‘MAKE IN INDIA’
IMPACT ON BIOSCIENCES SECTOR

BioAnalysis
I
n September 2014, Prime Minister Narendra
Modi launched ‘Make in India’ program, rolling
out the red carpet to investors through a string
of measures including easier norms and rules
aimed at transforming India into a manufactur-
ing hub. BioPharma and Medtech were amongst
the 25 sectors that the government has identified and are
covered under the ‘Make in India’ plan. In recent times,
the campaign has created a lot of buzz, and has been a
topic of discussion at various business meetings. But has
any concrete steps been taken to boost this campaign es-
pecially in the biopharma and medtech sector? BioSpec-
trum tries to find out.
Impact of Make in India
There are some contradictory response to this. Though,
some believe that the campaign has failed to meet expec-
tations, some say it is a move in the right direction.
Speaking for the Medtech sector, Dr GSK Velu, founder
and managing director, Trivitron Group of Companies,
said “There are some significant benefits to this move
which will bring down the cost of medical equipment and
devices by 30 to 50 percent and also the uptime of equip-
ment in tier 2/3/4 towns will improve due to easier avail-
ability of spare parts. Local production will also lead to
additional employment generation, local RD and local
skill development programmes. Moreover, the PM’s vi-
sion has already attracted some major MNC players to set
up low cost manufacturing units in India to serve emerg-
ing market.”
The campaign has a positive impact on the generic phar-
maceutical firms, but for the biotech sector nothing sig-
nificant, feels N Venkat, co-founder, Vyome Biosciences.
He said, “Nothing much is yet visible in the PM’s ‘Make
in India’ campaign for the biosciences/medtech industry
and the players. The policies and investment thesis only
talks about increase in investment but concrete plans
should be brought to the fore. There has been a positive
effect, though, for the generic pharmaceutical players.”
Any positive outcomes?
“Definitely, with the Indian government supporting
‘Make in India’ all industries including healthcare are
further sharpening their focus in India,” said Ms Rekha
Ranganathan - Global General Manager, Mobile Surgery
Head, Philips HIC.
She added, “We expect even higher contribution from
the region in the months to come. HIC, which aims at
enhancing access to affordable healthcare in emerging
markets, as well as across the globe, is a key contributor
to Philips globally. There has been substantial increase
in our healthcare footprint. Over the last few years, the
facility has successfully launched five global products,
doubled unit growth and filed multiple patents, making
it a very important hub globally.”
Currently the government is willing to listen to the views
of Indian manufacturers in this segment and implement
changes to the tariff structure and regulatory structure in
the upcoming budget.
“Indian manufacturers are of the view government should
do away with 100% customs duty exemption for all prod-
uct categories as this has not benefited the end patients
over the past two decades. As per recent reports in the
media, a Drug Eluting Stent which is being manufactured
for Rs 5,000 is being imported to India for around Rs
40,000 with nil customs duty and in the end patient pays
Dr. GSK Velu
Trivitron
N Venkat
Vyome Biosciences
Rekha Ranganathan
Phillips

BioAnalysis
around Rs 1.5 lakh for the same. Hence there is no ratio-
nale for zero customs duty for any finished goods imports
and there should be at least 20% customs duty exemp-
tion between finished goods imports and raw material/
components import for ultimate manufacturing in the
country,” Dr Velu said.
“No positive effects have been visible yet for the biotech-
nology industry, except for the momentum that Indian
pharmaceutical industry already has by being a global
supplier of pharma generics. The trickledown effect
might be visible some time later,” said N Venkat.
Though, at present, the effect might be negligible, the in-
dustry is optimistic that the future holds good promise
for the campaign.
Major announcements/initiatives to
promote the sectors
Indian medical devices industry is extremely import de-
pendent -- almost 70 percent. To boost domestic manu-
facturing, the government has announced 100 percent
FDI in medical devices.
Speaking for the biotech sector N Venkat says that as yet
there hasn’t been any major announcement which com-
plements or supports the campaign for the biotechnology
industry.
It may be noted that to realize the vision of Modi’s ‘Make
in India’, department of chemicals and fertilizers had set
up three task force, among which one was on ‘Promotion
of domestic production of high end medical devices and
pharmaceutical manufacturing equipment’.
The task force has given recommendations to address
concerns and constraints facing the sector and suggested
measures that would augment domestic production of
medical devices. The task force has recommended mea-
sures to enhance policy and institutional support; sug-
gested strengthening of infrastructural support; and, rec-
ommended fiscal and financial support to the sector. In
addition, the task force has also recommended measures
for creating an institutional set-up for efficacy and safety
testing, promoting skill development aligned to the need
of the industry, strengthening the RD capability of the
sector, pricing strategy for the sector and conducive regu-
latory environment.
Making India a manufacturing hub
So, how do we make India a manufacturing hub as envi-
sioned by our PM. “By giving more significance to Indian
companies than giving more importance to foreign com-
panies can transform the country into a manufacturing
hub,” said Dr Velu.
In order to establish a region as a manufacturing hub
two main pre-requisites must be met: talent and supplier
base.
“There is a very young, yet specialized population when it
comes to RD and engineering in India. We have a large
base of this population and we need to invest in train-
ing this talent to become leaders in healthcare RD and
businesses. The supplier base in India is still at the infant
stage in healthcare and we should focus on investing in
increasing the supply base and ensure that we have global
standards. Philips’ focus is to really develop and nurture
this local base to further innovate and manufacture out of
India,” said Ms Ranganathan.
N Venkat said following measure can be taken to make
the campaign a success and make India a biotechnology
manufacturing hub viz. creation of an ecosystem for de-
velopment and capital availability for biosciences innova-
tion and manufacturing units, creation of optimal, effec-
tive and speedy regulatory system for approvals, better
export incentives for biotechnology industry with respect
to technology licensing in addition to products’ exports,
to motivate novel biotechnology oriented companies to
invest in and increase exports and lucrative incentives
for the global biotechnology players to set up their opera-
tions in India and collaborate with Indian biotechnology
firms for joint product and technology development.
Time to finally turn discussions into decisions. BS
Ayesha Siddiqui
To establish a region as a
manufacturing hub 2 pre-requisites
must be met: talent and supplier

BIO
PHARMA
BIO
RESEARCH
BIO
SUPPLIERS
BIO
INDUSTRIAL
BIO
SCIENCE CARES
BIO
ANALYSIS
BIO
AGRI
CROS
BIO
INFORMATICS
Connect to your
target audience
in the industry
Connect to your
target audience
in the industry

*Amount in INR
BioSpectrum India Magazine
Corporate Management
Sales Marketing
Scientific / Research Management
Others (please specify)
Biotechnology
BioPharma
Medical Technology
Bioinformatics
Finance / Legal
HR Administration
Non - Managerial
Academia
QA QC
BioServices
Distributor / Dealer / Supplier
Training / Education Institute
Government
Research
Healthcare
Legal Services / Patent Services
Media / Event Organisers
Venture Capitalist / Investor
Consultation
Others (please specify)
Mail this form along with your Cheque/DD or Credit Card details to:
MM Activ Sci-Tech Communications Pvt. Ltd., No. 9, UNI Building, Thimmaiah Road, Millers Tank Bund, Bangalore - 560 052
Ph: +91-80-4113 1912 | Fax: +91-80-4113 1914 | To subscribe online visit, bit.ly/BSI-Subscription | www.biospectrumindia.com

BioColumn
20th
Anniversary
of the global
commercialization
of GM crops
Clive James
Founder and Emeritus Chair, ISAAA
FACT 1.
2015 marked the 20th year of the
successful commercialization of
biotech crops. An unprecedented
cumulative hectarage of 2 billion
hectares of biotech crops, equiva-
lent to twice the total land mass
of the US (937 million hectares),
were successfully cultivated glob-
ally in up to 28 countries annually,
in the 20-year period 1996 to 2015;
farmer benefits for 1996 to 2015
were conservatively estimated at
over $150 billion. Up to ~18 million
risk-averse farmers benefitted an-
nually, of whom, remarkably, 90%
were small, resource-poor farmers
in developing countries.
FACT 2.
Progress with adoption in the first
20 years. Following a remarkable
run of 19 years of consecutive yearly
growth from 1996 to 2014, the an-
nual global hectarage of biotech
crops peaked at 181.5 million in
2014, compared with 179.7 million
hectares in 2015, equivalent to a
net marginal year-to-year decrease
of 1.0% between 2014 and 2015.
Some countries increased their to-
tal plantings, whilst others reduced
their hectarage principally due
to the current low prices of com-
modity crops; these hectarage de-
creases are likely to revert to higher
hectarage levels when crop prices
improve. The global hectarage of
biotech crops increased 100-fold
from 1.7 million hectares in 1996 to
179.7 million hectares in 2015, mak-
ing biotech crops the fastest adopt-
ed crop technology in recent times.
FACT 3.
For the 4th consecutive year, de-
veloping countries planted more
biotech crops. In 2015, Latin
American, Asian and African farm-
ers collectively grew 97.1 million
BioColumn

BioColumn
hectares or 54% of the global 179.7
million biotech hectares (versus 53%
in 2014) compared with industrial
countries at 82.6 million hectares or
46% (versus 47% in 2014); this trend
is likely to continue. Of the 28 coun-
tries planting biotech crops in 2015,
the majority, 20, were developing
and 8 industrial.
FACT 4.
Stacked traits occupied ~33% of
the global 179.7 million hectares.
Stacked traits are favored by farmers
for all 3 major biotech crops. Stacked
traits increased from 51.4 million
hectares in 2014 to 58.5 million hect-
ares in 2015 – an increase of 7.1 mil-
lion hectares equivalent to a 14% in-
crease. 14 countries planted stacked
biotech crops with two or more traits
in 2015, of which 11 were developing
countries. Vietnam planted a stacked
biotech Bt/HT maize as its first bio-
tech crop in 2015.
FACT 5.
Selected highlights in developing
countries in 2015. Latin America had
the largest hectarage, led by Brazil,
followed by Argentina. In Asia, Viet-
nam planted for the first time, and
Bangladesh’s political will advanced
planting of Bt eggplant and identi-
fied Golden Rice, biotech potato
and cotton as future biotech targets.
The Philippines has grown biotech
maize successfully for 13 years, and
is appealing a recent Supreme Court
decision on biotech crops, whilst
Indonesia is close to approving a
home-grown drought-tolerant sug-
arcane. China continues to benefit
significantly from Bt cotton ($18 bil-
lion for 1997 to 2014), and notably
ChemChina recently bid $43 billion
for Syngenta. In 2015, India became
the #1 cotton producer in the world,
to which Bt cotton made a significant
contribution – benefits for the period
2002 to 2014 are estimated at $18
billion. Africa progressed despite a
devastating drought in South Africa
resulting in a decrease in intended
plantings of ~700,000 hectares in
2015 – a massive 23% decrease.
This underscores yet again the life-
threatening importance of drought in
Africa, where fortunately, the WEMA
biotech drought-tolerant maize is on
track for release in 2017. Sudan in-
creased Bt cotton hectarage by 30%
to 1,20,000 hectares in 2015, whilst
various factors precluded a higher
hectarage in Burkina Faso. In 2015,
importantly, 8 African countries
field-tested, pro-poor, priority Afri-
can crops, the penultimate step prior
to approval.
FACT 6.
Major developments in the US in
2015. Progress on many fronts in-
cluding: several ‘firsts’ in approvals
and commercializations of ‘new’ GM
crops, such as Innatepotatoes and
ArcticApples; commercialization of
the first non-transgenic genome-ed-
ited crop, SU Canola; first time ap-
proval of a GM animal food product,
GM salmon, for human consump-
tion; and increasing RD use of the
powerful genome editing technology,
named CRISPR (Clustered Regularly
Interspersed Short Palindromic Re-
peats); high adoption of first biotech
drought tolerant maize (see below).
Dow and DuPont merged to form
DowDuPont.
FACT 7.
High adoption of the first biotech
drought-tolerant maize planted in
the US. Biotech Drought Gardmaize,
first planted in the US in 2013, in-
creased 15-fold from 50,000 hectares
in 2013 to 8,10,000 hectares in 2015
reflecting high farmer acceptance.
The same event has been donated
to the public-private partnership
WEMA (Water Efficient Maize for
Africa), aimed at the timely delivery
of a biotech drought tolerant maize to
selected countries in Africa by 2017.
FACT 8.
Status of biotech crops in the EU. The
same five EU countries continued to
plant 1,16,870 hectares of Bt maize,
down 18% from 2014. Hectares de-
creased in all countries due to several
factors including, less maize planted,
disincentives for farmers with oner-
ous reporting.
FACT 9.
Benefits offered by biotech crops. A
global meta-analysis of 147 studies
for the last 20 years reported that
“on average, GM technology adop-
tion has reduced chemical pesticide
use by 37%, increased crop yields by
22%, and increased farmer profits by
68%” (Qaim et al, 2014). These find-
ings corroborate results from other
annual global studies (Brookes et al,
2015). From 1996 to 2014, biotech
crops contributed to food security,
sustainability and the environment/
climate change by increasing crop
production valued at $150 billion;
providing a better environment, by
saving 584 million kg a.i. of pesti-
cides; in 2014 alone, reducing CO2
emissions by 27 billion kg, equivalent
to taking 12 million cars off the road
for one year; conserving biodiversity
by saving 152 million hectares of land
from 1996-2014; and helped allevi-
ate poverty for ~16.5 million small
farmers and their families totaling
~65 million people, who are some of
the poorest people in the world. Bio-
tech crops are essential but are not a
panacea – adherence to good farm-
ing practices such as rotations and
resistance management, are a must
China continues
to benefit
significantly from
Bt cotton

BioColumn
biotech crop highlights in 2015
Million hectares
biotech crops
countries
plantedin
179.7
2 billion hectares of biotech crops
planted in ~28 countries since 1996
28
Fastest adopted crop technology in recent times
countries growing biotech crops
contribution oF biotech crops to Food security, sustainability climate change
major biotech crops
Million
farMers18
canola
5%
others
1%
soybean
51%
maize
30%
cotton
13%
Source: James, Clive. 2015. 20th
Anniversary (1996-2015) of the Global
Commercialization of Biotech Crops and Biotech Crop Highlights in
2015. ISAAA Brief No. 51.
#gmcrops2015
#isaaareport2015
vietnam
firstcommercialplanting of
stacked biotech maize in
herbicide tolerance is
the dominant trait deployed
in soybean, maize, canola,
cotton, sugar beet
alfalfa
herbicide
tolerance
53%
stacked traits
33%
insect resistance (14%)
(area in million hectares)
top 5 countries growing biotech crops:
20developing 8industrial
44.2
24.5
11.6
11
usa
Brazil
argentina
india
canada
70.9
more aFFordable
Food
increases crop productivity
reduces production costs
decreases co2 emissions
biotech cotton has made
significant contribution to the
incomes of 16.5 million
poor farmers their families
in india, china, pakistan, Brazil,
argentina, Burkina faso, myanmar, mexico,
sudan, paraguay south africasavings on fossil-Based fuels
reduces
greenhouse
gases
helps mitigate
climate change
better livelihoods From
higher yields
contriButes to alleviation of
poverty and hunger
land saving
technology
conserves Biodiversity
prevents
deforestation
lowers pesticide use
reduces agriculture’s
eco-footprint
helps farmers earn reasonaBle incomes
isaaa.org @isaaa_org isaaavideos
www.isaaa.org
For more information, visit ISAAA website:

BioColumn
for biotech crops as they are for con-
ventional crops.
FACT 10.
Future prospects. Three domains
merit consideration. Firstly, high rates
of adoption (90% to 100%) in current
major biotech markets leave little
room for expansion; however, there
is a significant potential in other ‘new’
countries for selected products, such
as biotech maize, which has a poten-
tial of at least ~100 million hectares
globally, 60 million ha in Asia (35 mil-
lion ha in China alone), and 35 million
ha in Africa. Secondly, there are more
than 85 potential new products in the
pipeline now being field-tested, the
penultimate step to approval. They
include the WEMA-derived biotech
drought tolerant maize expected to
be released in Africa in 2017, Golden
Rice in Asia, and fortified bananas
COMMITTED TO EXCELLENCE
Thermolab Group, Thermolab House,
Plot No. 19, Vasai Municipal Ind. Area,
Umela Road, Vasai (West) - 401 207, Maharashtra, India
(T) +91-250-2323156, 2324866/7 l (F) +91-250-2321656
(E) info@thermolabgroup.com l (W) www.thermolabgroup.com
Thermolab Group of Companies:
Thermolab Scientific Equipments Pvt. Ltd.
Thermolab Testing Services Pvt. Ltd.
Thermolab Sales Services Pvt. Ltd.
Thermolab Healthcare Pvt. Ltd.
Thermolab Analyticals
offers a timely and powerful unique
set of significant comparative advan-
tages over conventional and GM crops
in four domains: precision, speed, cost
and regulation. Unlike the onerous
regulation that currently applies to
transgenics, genome-edited products
logically lend themselves for science-
based, fit-for-purpose, proportionate,
and non-onerous regulation.
A forward looking strategy has been
proposed (Flavell, 2015) featuring
the troika of transgenes, genome ed-
iting and microbes (the use of plant
microbiomes as a new source of addi-
tional genes to modify plant traits) to
increase crop productivity, in a ‘sus-
tainable intensification’ mode, which
in turn can viably contribute to the
noble and paramount goals of food
security and the alleviation of hunger
and poverty. BS
and pest resistant cowpea look prom-
ising in Africa. Institutionally, public-
private partnerships (PPP) have been
successful in developing and deliver-
ing approved products to farmers.
Thirdly, the advent of genome-edited
crops may be the most important de-
velopment identified by today’s scien-
tific community.
A recent and promising application
is the powerful technology, named
CRISPR. Many well-informed observ-
ers are of the view that genome editing
A forward looking
strategy has been
proposed featuring
transgenes, genome
editing and microbes

BioTalk
India will
become a
leader in
Medtech
space
Ms Elizabeth Bailey
Director, Consortium for Affordable
Medical Technologies (CAMTech)
L
aunched in 2013, CAMTech India’s (Con-
sortium for Affordable Medical Tech-
nologies) mission is to accelerate medical
technology innovation and build entre-
preneurial capacity to improve health out-
comes in low-and middle-income countries
(LMICs). Its program involves clinical summits, hack-
athons, innovation awards, entrepreneur bootcamps, ac-
celerator programs, co-creation labs and an online plat-
form to support global health innovators continuously
and across geographic boundaries.
The director of CAMTech, Ms Elizabeth Bailey, spoke ex-
clusively to BioSpectrum, voicing her thoughts on India’s
healthcare challenges, accelerating and commercializing
innovations, CAMTech’s India plans, collaborations, and
addressing India’s obstacles in the medtech space. Ex-
cerpts:
Q What are the current pressing healthcare
challenges that you see in India?
A
Through our work in India, and specifically since
the launch of the CAMTech INDIA program, CAM-
Tech has identified critical health challenges relat-
ed to reproductive, maternal and child health (RMNCH)
in India.
The program aims to accelerate the development and
adoption of new technologies to address preventable
causes of death among women and children in India.

BioTalk
Specific areas that our events and initiatives have focused
on include RMNCH challenges like newborn survival,
safe births and family planning.
In addition to RMNCH, our hackathon in last year focused
on innovation in the diagnosis, prevention and treatment
of diabetes in India – a significant area of unmet needs.
Q
How are these challenges, according to
you, different in India compared to other
LMIC countries?
A
Neonatal mortality in India contributes to about a
quarter of the world’s total number of infant deaths
each year, and 99% of maternal and newborn
deaths occur in the developing world more broadly.
While there are differences in the Indian ecosystem, we
have seen some exciting opportunities for innovation in
India to help solve clinical problems on a global scale.
Issues of access to quality care, for example, are not
unique to India, but in order for innovations to be suc-
cessfully adopted here, they need to have local buy-in
with an understanding of the local context.
This is why CAMTech focuses on sourcing local innova-
tion that involves local stakeholders.
As we have seen in recent years, diabetes has become one
of the leading causes of death in India, which in turn has
serious implications on the healthcare system in India.
This has motivated CAMTech to organize events that will
work with local innovators in India to develop solutions
that will help to address the epidemic in this country.
Q How is CAMTech involved in addressing
these challenges?
A
The process begins by identifying specific clinical
challenges from our network of clinical, academic
and industry partners.
We work to tackle these challenges through medical tech-
nology hackathons and funding programs, which act as a
way to crowdsource innovation and bring game-changing
Diabetes has become one of
the leading causes of death in
India, which in turn has serious
implications
technological solutions forward.
The most promising of these solutions are sourced and de-
veloped through CAMTech’s ecosystem of incubation re-
sources that help build and foster entrepreneurial capacity.
Our program involves clinical summits, hackathons, in-
novation awards, entrepreneur bootcamps, accelerator
programs, co-creation labs and an online platform to
support global health innovators continuously and across
geographic boundaries.
Q How do you view India’s medtech
landscape?
A
We see so much promise in India’s medtech land-
scape. The passion and talent alone is unprecedent-
ed, and the entrepreneurial culture seems to be
gaining momentum.
What has been most exciting is to see how much innova-
tors can accomplish, even with limited resources, com-
pared to groups in the West.
It is much more expensive to do business and launch ven-
tures in the West, and I think India has a real competitive
advantage because of the lower cost of doing business.
I have no doubt that India will become a leader in the
medtech space over the next decade, and it will have a
huge impact not only on India but on other emerging and
developing countries as well.
And we see enormous potential for reverse innovation
where new health technologies coming from India can
help to reduce costs and improve the quality of care in
markets like the US.
Q
In India, what are the major challenges
that you have experienced in moving an
innovation forward?
A
The entire CAMTech team and all of our partners in
India have been really inspired by the community
of health innovators across the country.
There is a growing network of clinicians, engineers and
entrepreneurs who are passionate about making a differ-
ence and improving health in India.
The biggest challenge however, seems to be the fragmen-
tation of the medtech innovation ecosystem.
There are many people and organizations in India doing

BioTalk
meaningful and impactful work, but they are not always
able to work cohesively.
One of the primary goals of the CAMTech program has
been to bring these disparate groups together to work
more collaboratively to accelerate the whole process of
innovation.
There has also been a dearth of resources and support for
early-stage health innovators, and we are keenly focused
on filling that gap with things like increasing mentorship,
funding, technical assistance and partnership opportuni-
ties for Indian innovators.
Q
Briefly explain what are the key elements
needed to successfully accelerate
healthcare medtech innovations in India.
A
First and foremost, we want to start with real and
identified clinical challenges.
All too often, technologies are developed in isolation from
clinicians, and that is why we have ended up with many
technologies that are not used despite being available.
CAMTech works closely with our clinical partners to
identify challenges and have those drive the technology
innovation process. We also believe that successful tech-
nologies incorporate business, medicine and technology
right from the start.
Successful innovations are ones that are not only tech-
nically-innovative, but also clinically-impactful and com-
mercially-viable.
No one group or discipline should be innovating in isola-
tion, and cross-disciplinary teams are the ones who are
most successful and expedite the entire process.
In terms of what early-stage innovators need in this space,
we often hear that there is not a roadmap or clear place
to go to get guidance or needed information or resources.
CAMTech and our partners are working to create an eco-
system that can support global health innovators through
the entire process of technology development, commer-
cialization and market adoption and scale.
Q Currently how does the healthcare
entrepreneurship scene look like in India?
A
As I’ve mentioned, the innovator community in In-
dia and their desire to make a difference has in-
spired us. We do hear from those in our innovator
network that it’s not necessarily celebrated to become an
entrepreneur, and that parental expectations influence
many people to take a more traditional professional path.
We see that changing, however, but it has been slower
outside of internet start-ups and particularly slow in the
medtech space.
The more that industry, government bodies and academia
can do to promote and celebrate entrepreneurship, the
more health start-ups we’ll see. The passion is definitely
there, but they also need a little push to get comfortable
with all the risks a start-up presents.
Q
Tell us about your key partners and the
role they play in helping healthcare
innovations.
A
CAMTech’s broad range of clinical, academic and
industry partners play a large role in the success
and impact that our organization has in India and
throughout the world.
Our partners provide ongoing clinical expertise and prob-
lem identification, event sponsorship, as well as mentor-
ship, monetary awards and incubation support to global
health innovators.

BSI_May-2016_Raj Gunashekar

Recommended

Recommended

More Related Content

Similar to BSI_May-2016_Raj Gunashekar

Similar to BSI_May-2016_Raj Gunashekar (20)

More from Raj Gunashekar

More from Raj Gunashekar (19)

BSI_May-2016_Raj Gunashekar